Advanced Clinical Announces Bernice Welles as a Core Member of its Strategic Advisory Ecosystem

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

Bannockburn, Ill. (Vocus) September 30, 2010

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

As a strategic advisor, Bernice Welles has contributed to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies. Bernice has been a key driver in the development and regulatory approval of drugs, biologics, devices as well as combination therapies across multiple therapeutic areas. “Moving a drug and/or biologic from development to approval is, possibly, the hardest earned process in the Life Sciences industry,” says Bernice Welles, Advanced Clinical Strategic Advisor.

Welles’ accomplishments span several leadership roles in companies at different stages of growth. At Genentech, Welles was appointed to several management positions to drive the drug and biologics development portfolio across multiple therapeutic areas. Two of Welles positions included: Senior Director of the Specialty Therapeutics Unit and Vice President of Product Development. One important program that Welles progressed was the Lucentis injection for wet age-related macular degeneration (AMD). AMD is a disease of the eye that is the leading cause of blindness in older Americans and causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities. By moving forward this program, several thousand patients were able to be treated.

Welles held a Venture Partner position at MPM Capital LLP, where she participated in discussions on medical devices and helped assess device instruments. At MPM, Welles also took the lead on several investments and helped portfolio companies such as CoTherix maneuver the regulatory process leading to an early approval for Ventavis®, a new therapy for pulmonary hypertension.

Welles currently holds executive positions as CEO of Alquest Therapeutics Inc. and Vice President, Clinical and Regulatory, of Enject Inc., both innovative biotechnology startup companies.

With years of experience heading teams across functional areas, Welles credits integration as being one of the keys to her success. Using her capability to integrate the knowledge she has gained during her career, Welles is able to pull together all of the elements of clinical and regulatory as well as leverage the science behind development programs to create a significant, positive impact on the Life Sciences industry.

“I am proud to be working with Advanced Clinical,” said Bernice Welles. “Being part of this expert strategic advisory team allows me to continue to work with a topflight team to create new levels of R&D Productivity for companies in Life Sciences and bring much needed treatments to the market for those who need them.”

About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com/.

Contact:
Rosemarie Truman
rtruman@advancedclinical.com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208

Key Levers for R&D Effectiveness and Efficiency

Optimization needs to occur in two ways: “what is done” (effectiveness) and “how it is done” (efficiency). Key R&D areas that should be re-aligned to increase effectiveness include:

• From Opportunistic to Focused Innovation: Drive rigor into the selection of new products/solutions. Capitalize more effectively on new ideas that present great opportunities for the company


• From Full Integration to Partnership: Partner with other companies to manage risk and return on R&D capabilities; outsource capabilities that aren’t central to company strategy


• From Therapeutic Problem to Differentiated Customer Solutions: Shift from therapeutic R&D that addresses diseases to meeting patients’ needs through curing ailments and fully managing patient conditions. Payors and consumers are demanding solutions, as well as differentiation


• From a Functional to an Integrated Business Model: Map out an integrated R&D model focused on a specialized therapeutic, customer or scientific area to provide tighter coordination and more rapid decision-making; use comparative effectiveness to bring to market the right drug, biological entity and/or medical device
  

While “what companies do” creates 70-80% of problems for R&D, companies must not forget to also focus on the other 20%: addressing efficiency gaps to streamline its processes, people and technology. Efficiency gaps are broken out as follows: Technology and Resource Management, Project and Resource Management, Product Development Processes, R&D Investment Guidelines, and Asset, Knowledge and IP Management.

• Technology and Resource Management: There are few standard technologies to support R&D processes. Where technologies are used, they are used inconsistently, with overlapping duplicate efforts. There is no comprehensive application and information architecture that would allow Life Sciences companies to understand performance across ALL product development and clinical trial efforts. An integrated eClinical platform would provide fully integrated business and technology solutions to minimize duplication and harmonize data


• Project and Resource Management: Proper project management and associated resource allocation is critical to ensure the right resources are on the right projects at the right time. Project management needs to include a comprehensive, cross-functional approach including: risk management, decision management, issue management, change management, quality management, knowledge management as well as service/metrics management


• Product Development Processes: R&D also suffers from inconsistent development processes, poor collaboration, and weak customer insight. Developing, implementing and adhering to a standard set of product development processes (e.g. BLAs for vaccines), which include regular collaboration and market insight injection, will enable R&D to develop the drugs that consumers actually want and bring them to market quickly


• R&D Investment Guidelines: With tightening budgets, talent turnover, and increased competition, an R&D investment strategy is needed for sustained growth; companies need guidelines to mitigate risks and accelerate clinical trial time while reducing spending


• Asset, Knowledge and IP Management: Proactive collection of knowledge is critical to ensure continuous learning and constant improvement of current practices. In addition, codification of knowledge into repeatable processes and methods is also important to create intellectual property assets

Visit our Website for more on ILRDP Transformation! http://www.advancedclinical.com/

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Our Website: http://www.advancedclinical.com

Advancing Discoveries: Adaptive Designs in Clinical Trials

What is Adaptive?

In the past several decades there has been a recognized trend of increased spending within pharmaceutical, biopharmaceutical, medical device as well as biotechnology research without a proportional increase in success rate of clinical trials - there used to be 8 IDAs for 1 commercial success; now 16 INDs for 1 commercial success. Some of these could be due to diminishing improvement margins for new drugs, unchanging failure rates, escalating costs, and other clinical limitations. By advancing discoveries, Advanced Clinical seeks to determine the most efficient and effective way to conduct clinical trials without decreasing the safety or efficacy of the trial. Adaptive designs have recently become the frontrunner in advancing clinical trials. Adaptive designs are clinical study designs that utilize accumulating clinical data to modify the study as it progresses, without undermining the validity and integrity of the trial. Not all clinical trials are suited for adaptive design. Stay tuned for our next blog post on Adaptive Risk Management, and FDA accepted adaptive designs/regulatory perspectives!

Why do it?

Adaptive clinical designs save resources and increases efficiency of the clinical trial. Greater flexibility within the adaptive design framework can translate into better treatment of patients within trials (stopping ineffective/dangerous doses early), more efficient drug development, and better use of available resources (need for less patients). Adaptive designs are not only advantageous to drug development, but they are ethically beneficial to the patients. Trials can be cut earlier if they are ineffective, thus efficiently and effectively ensuring patients are well served with the appropriate dosages. This is most important not only because the clinical trial can save resources by cutting off ineffective arms, but the trial can also stop harmful treatments early on in order to prevent patient harm and preserve the overall safety of the clinical trial. Adaptive designs for clinical trials provide efficient tools to demonstrate the safety and effectiveness of new medical products in faster timeframes with more certainty, at lower costs, and with better information.

Types of Adaptive Design Options (click picture to view!)

With adaptive study design, there are many design options that affect different aspects of a trial. above are some of the more widely known adaptive options.

What are the Pros and Cons of Adaptive Design? (click picture to view!)

Adaptive designs, though having a lot of advantages, can have some disadvantages as well. Stay tuned for our next blog posting about the risks and regulatory perspectives surrounding adaptive designs.

Also, don't forget to add our facebook page! www.facebook.com/advclinical

See www.advancedclinical.com

How do you advance discoveries? EXTENDED THROUGH JULY!

Now, you have through July to enter to win an iPad and a mention in our winners press release!

Shorten clinical trials. Reduce risk. Reduce cost! We need YOUR ideas!

Eighty billion drugs are predicted to come off patent in the next three years. While some say this release of patents may save money for the healthcare system as a whole because generics will take the place of those coming off patent, there is no replacement for many drugs and there are patients that need these drugs. As a result, Pharmaceuticals and Biotech companies have two key imperatives:

• "Advance discoveries", aka, reduce clinical trial timelines


• Reduce the escalating costs and risks associated with drug development

A recent article in the Wall Street Journal "Clinical Trial Death Watch" (March 16th 2010) echoes these imperatives. The message from the Wall Street Journal article is: there is a resounding need for efficiency and effectiveness to accelerate clinical trials. Even the government is trying to help with the acceleration of clinical trials. One recent study focused on collaboration. There are, however, still many complex issues that create barriers to realizing these imperatives. See, Forbes (March 26th, 2010 "Research and Markets: Investigating Clinical Trial Costs").

Advanced Clinical wants to ask pharmaceutical, biotechnology, and medical device companies, “How do you advance discoveries?” What are the best practices you use to shorten clinical trials? How do you reduce risk and cost in drug development? Do you have a strong risk management approach, employee training, or metrics management? Advanced Clinical would like your ideas to create Industry Leading Trial Performance in clinical research.

Let us know how you advance discoveries here. If you win, your ideas will be part of our press release in July, and you will win an iPad!

For winning list announcement, you can follow Advanced Clinical on facebook or on one of our social networks:

Advanced Clinical Facebook Page
http://twitter.com/AdvClinical
http://youtube.com/AdvancedClinical
http://AdvancedClinical.blogspot.com
http://AdvancedClinical.wordpress.com

See www.advancedclinical.com

Advanced Clinical: Asset Delivery

Upon signing your discovery to Advanced Clinical, you will find there are a lot of assets with your decision. Advanced Clinical is home of the Industry Leading Trial Performance Method, a method which carefully combines strategy, management, structures and execution strategies to advance discoveries.

Parts of our ILTP method include risk management, team integration, continuous learning, ramping/onboarding, project management with supply and demand management, recruiting and sourcing, and marketing.

Advanced Clinical takes a three-part overall approach to trials:

• Collaborate: One team approach, we work together
• Innovate: Work together to find the best technology and team members to find new ways of testing and advancing your discovery, apply the Industry Leading Trial Performance Method
• Optimize: Enhance the trial after it has begun with continuous learning and training, make step-change improvements to better the trial

Does this sound like a great way to advance discoveries? We think it is. Enter our “how do you advance discoveries” contest and your company could win an iPad and get a mention in our press release.

See www.advancedclinical.com

Team Integration from Advanced Clinical

Many times there is limited or no effort taken to create a joint view of the goals that should be achieved during a clinical trial. As a result, the clinical team is not productive as a unit as they become "disengaged". Disengaged employees are 33% less productive on average according to several reports*.

This loss of productivity is unacceptable at Advanced Clinical. We want to give you your dream team.

This costs companies a lot of money, risk, and time. Several studies* have been performed on the linkage among team building, team cohesion, and team performance. An integrated team will achieve improvements in performance by developing the right "Team Culture" and adopting the behaviors needed to support and reinforce that culture. A strong Team Culture leads to reduction of waste, duplication, unnecessary processes and procedures. Most importantly, team culture leads to the willingness to succeed.

To keep clinicians and consultants in the loop with your project, Advanced Clinical has built a "Team Integration Method." Our method succeeds in creating a completely harmonized team, whether working on-site or off-site to ensure maximum employee engagement, productivity and overall performance.

Advanced Clinical believes our consultants should be "close" with not only their colleagues on a project, but the project managers and your colleagues as well. Bonding exercises and introductions take place before our clinical trials. Mutual respect and complete communication is ongoing to keep workplace karma good, and, ultimately, to ensure successful trials completion. Goal setting keeps their eyes on the prize, and personality awareness makes better working relationships.

Does this sound like a good way to advance discoveries? We think it is. Enter our “How do you advance discoveries” contest and your company could be mentioned in our press release.

Enter today.

See www.advancedclinical.com


*Sources:

Bloom, G. A., Stevens, D. E., and Wickwire, T. L. (2003). Expert coaches’ perceptions of team building. Journal of Applied Sport Psychology. 15: 129-143.
Crron, A.V., Brawley, L.R., and Widmeyer, W. N. (1985). The Group Environment Questionnaire.
Carron, A.V., Bray, S.R., and Eys, M.A. (2002).Team cohesion and team success in sport. Journal of Sports Sciences, 20, 119-126.
Dirks, K.T. (2000). Trust in leadership and team performance: evidence from NCAA basketball. Journal of Applied Psychology, 85(6) 1004-1012.
Ebbeck, V. and Gibbons, S. L. (1998). The effect of a team building program on the self-conceptions of grade 6 and 7 physical education students. Journal of Sport and Exercise Psychology, 20; 300-310.
Everett, J. J., Smith, R. E., and Williams, K.D. (1992). Effects of team cohesion and identifiably on social loafing in relay swimming performance. International Journal of Sport Psychology. 23: 311-324.
Kozub, S.A. & Button, C.J. (2000). The influence of a competitive outcome on perceptions of cohesion in rugby and swimming teams. International Journal of Sport Psychology. 31: 82-95.
Landers, D. M. and Luschen, G. (1974). Team performance outcomes and the cohesiveness of competitive coacting groups. International Review of Sports Sociology. 5: 57-69.
Martin, R. and Davids, K. (1995). The effects of group development techniques on a professional athletic team. The Journal of Social Psychology, 135 (4) 533-535.
Meyer, B.B., Wenger, M.S. (1998). Athletes and adventure education: An Empirical Investigation. International Journal of Sport Psychology, 29, 243-266.
Murphy, J. M. (2001). The effect of a one-time team building exercise on team cohesion.
Sencecal, J., Loughead, T.M., and Bloom (2008). A season-long team-building intervention: examining the effect of team goal setting on cohesion. Journal of Sport & Exercise Psychology, 30, 186-199.

Advanced Clinical launches “How Do You Advance Discoveries?” contest

Shorten clinical trials. Reduce risk. Reduce cost! We need YOUR ideas!

Eighty billion drugs are predicted to come off patent in the next three years. While some say this release of patents may save money for the healthcare system as a whole because generics will take the place of those coming off patent, there is no replacement for many drugs and there are patients that need these drugs. As a result, Pharmaceuticals and Biotech companies have two key imperatives:

• “Advance discoveries”, aka, reduce clinical trial timelines
  
• Reduce the escalating costs and risks associated with drug development

A recent article in the Wall Street Journal “Clinical Trial Death Watch” (March 16th 2010) echoes these imperatives. The message from the Wall Street Journal article is: there is a resounding need for efficiency and effectiveness to accelerate clinical trials. Even the government is trying to help with the acceleration of clinical trials. One recent study focused on collaboration. There are, however, still many complex issues that create barriers to realizing these imperatives. See, Forbes (March 26th, 2010 “Research and Markets: Investigating Clinical Trial Costs“).

Advanced Clinical wants to offer pharmaceutical, biotechnology and medical device companies a chance to be in our press release by answering the question: "How do you accelerate a clinical trial"?

Is it by ensuring strong team chemistry/integration; using robust communication methods, etc? Is it something else? Advanced Clinical would like your ideas to create Industry Leading Trial Performance in clinical research.

Let us know how you advance discoveries here. If you win, your ideas will be part of our press release in the beginning of August! The winning list of ideas will be posted on August 1st, 2010.

How do you advance discoveries?

For winning list announcement, you can follow Advanced Clinical on facebook or on one of our social networks:

http://www.facebook.com/pages/Advanced-Clinical/310724322038?ref=search&sid=1468411198.3440133258..1
http://twitter.com/AdvClinical
http://youtube.com/AdvancedClinical
http://AdvancedClinical.blogspot.com
http://AdvancedClinical.wordpress.com

See www.advancedclinical.com